-Sample Letter of Medical Necessity
PROVIDER LETTERHEAD
Date
[Name of insurance]
Insurance address
RE: FAMILION® CPVT Test
PGxHealth
Letter of Medical Necessity (LMN)
Patient Name:
Subscriber/ID Number:
To whom it may concern:
I am writing on behalf of my patient and your subscriber [insert patient name], subscriber identification number [insert ID number], date of birth [insert DOB] to request pre-determination/prior authorization for CPT4 codes 83891 (1 unit), 83898 (41 units), 83904 (41 units), 83909 (41 units) and 83912 (1 unit) with diagnosis code(s) of [insert ICD9 codes].
Based on my evaluation and review of the available literature, I believe that the FAMILION CPVT genetic test, offered by PGxHealth, is warranted and medically necessary for [insert patient name]. There is no less expensive alternative available to obtain this urgently needed information.
Patient history, diagnosis, and treatment
[Include information here regarding the patient’s condition and history related to his/her predisposition for inherited cardiac channelopathies. Include information on the treatment up to this point and why a screening 12-lead ECG and exercise stress test would be insufficient to diagnose this patient and/or other appropriate history/documentation.]
Background information on CPVT
Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) is a potentially lethal inherited arrhythmogenic disorder characterized by adrenergically induced ventricular ectopy. CPVT is a disease that poses several challenges in both diagnosis and management. Approximately 1/10,000 individuals in the United States are affected and, if untreated, approximately 30% of CPVT patients will become symptomatic by age 10 and 80% by age 40, with an overall mortality rate of 30 – 50%.1,2,3 While there is no cure, medical management including combinations of lifestyle modification, β-blocker therapy and implantable cardioverter defibrillator (ICDs) can reduce the risk of untoward events.
The clinical presentation of CPVT is similar to that of another cardiac channelopathy, Long QT Syndrome (LQTS).1 Unlike LQTS, CPVT patients often have a normal resting electrocardiogram (ECG),3 with increasingly frequent and complex ventricular ectopy that emerges during exercise stress testing.1,2 However, in up to 20% of patients, formal exercise stress testing does not induce this characteristic pattern and as many as 30% of CPVT patients may be misdiagnosed as “Long QT with a normal QTc interval.”1,3,5
For patients who are potential carriers of a CPVT mutation, the FAMILION CPVT Test allows physicians to rule in definitively the presence of CPVT. By informing the differential diagnosis, the test results can aid physicians in recommending treatment directed to CPVT to reduce or eliminate cardiac events and lower the risk of premature death. For example, a patient with an LQT1 mutation will likely obtain reliable protection from β-blocker therapy, however, a patient with an LQT1-mimicking CPVT1 mutation may require a more aggressive treatment strategy that may include an implantable ICD.4 About 30% of CPVT patients treated with a beta-blocker ultimately require an ICD, with 50% subsequently receiving an appropriate shock.4 Family members of affected individuals may also be tested to determine their risk and need for intervention, especially given the lethality of CPVT when untreated.
Effectiveness of the FAMILION® CPVT genetic test for identifying mutations causing cardiac channelopathies
The FAMILION CPVT Test is a CLIA-certified test designed to identify mutations in the RYR2 ion channel gene in patients and their family members with this inherited cardiac channelopathy. The test is performed in a commercial laboratory that meets all applicable state and federal guidelines. The test has undergone extensive validation. Approximately 50-55% of individuals with CPVT have a mutation in the RYR2 gene.5 The FAMILION CPVT Test has a high analytical sensitivity; failure to detect an existing mutation in the RYR2 gene assayed is estimated to be <1%.
The value of genetic testing for CPVT has been extensively documented in the medical literature. In 2006, the American College of Cardiology, American Heart Association and the European Society of Cardiology jointly issued guidelines for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death recommending genetic testing for suspected carriers of CPVT.6 In this report, the authors state:
“Genetic analysis may help identify silent carriers of [CPVT-] related mutations; once identified, silent carriers may be treated with beta blockers to reduce the risk of cardiac events and may receive appropriate genetic counseling to assess the risk of transmitting the disease to offspring.”
The guideline recommendations by these well established organizations reflect data from multiple investigators that document the inadequacy of the clinical evaluation, including history, physical examination, ECG and exercise stress testing.
Thank you for your time and consideration of my request. Please contact me if you wish to discuss this patient’s treatment plan or require additional information. I can be reached at [insert telephone number].
Sincerely,
[insert name and signature]
Enclosures:
1Mohamed U. et al. Molecular and Electrophysiological Bases of Catecholaminergic Polymorphic Ventricular Tachycardia. J Cardiovasc Electrophysiol. 2007;18(7):791-797.
2Kontula K. et al. Catecholaminergic polymorphic ventricular tachycardia: recent mechanistic insights. Cardiovasc Res. 2005;67:379-387.
3Priori S. et al., Clinical and molecular characterization of patients with Catecholaminergic polymorphic ventricular tachycardia. Circulation. 2002:106:69-74.
3Napolitano C. et al., Diagnosis and treatment of catecholaminergic polymorphic ventricular tachycardia. Heart Rhythm. 2007;4:675-678.
4Priori S. et al., Clinical and molecular characterization of patients with Catecholaminergic polymorphic ventricular tachycardia. Circulation. 2002:106:69-74.
5Tester D. et al., Spectrum and prevalence of cardiac ryanodine receptor (RYR2) mutations in a cohort of unrelated patients referred explicitly for long QT syndrome genetic testing. Heart Rhythm. 2005;2:1099-1105.
6Zipes DP et al., ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death). Europace. 2006;8:746-837.